What the Body Does to Foliglurax in Healthy Volunteers
- Registration Number
- NCT04002895
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.
- Detailed Description
Six healthy men will swallow a liquid dose of 80 mg that is labelled with a small dose of radioactive tracer. Blood, urine and faeces will be collected to measure how much of the radioactivity gets into the blood stream and ends up in the urine and faeces. It is also measured how the body gets rid of the radioactivity and how quickly.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- Healthy men with a body mass index (BMI) of 19-30 kg/m2 (inclusive), and with a body weight of minimum 60 kg at the Screening Visit.
- The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
Other inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Foliglurax Foliglurax -
- Primary Outcome Measures
Name Time Method AUC(0-inf) foliglurax From day 1 until day 11 Area under the plasma concentration time curve from zero to infinity
Total amount of radioactivity excreted Before dosing until day 11 Cumulative amount of radioactivity excreted in urine and faeces
Cmax foliglurax From day 1 until day 11 Maximum observed plasma concentration
CL/F foliglurax From Day 1 until Day 11 Oral clearance for foliglurax in plasma
Total recovery of the administered dose Before dosing until day 11 % of dose in urine and faeces
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GB1050 Covance
🇬🇧Leeds, United Kingdom